Ethics

The way forward involves not only preventing negligence and fraud, but also facilitating therapeutic exchanges between various healthcare providers and their patients United States physicians, like their Australian counterparts, are deeply interested in the legal and ethical issues surrounding patient use of complementary and alternative medicine (CAM) therapies.1-3 Key legal questions of concern to physicians include (i) malpractice liability for negligent care and for inadequate informed consent; (ii) licensure and credentialling; (iii) scope of practice (the legally authorised practice boundaries for non-physicians, including CAM providers); (iv) regulation of dietary supplements; (v) professional discipline; (vi) third-party reimbursement; and (vii) healthcare fraud.1 This article briefly highlights key aspects of the first and second issues, comparing them, where possible, with the situation in Australia, and then brings an ethical perspective to the discussion. Duty of care regarding informed consentA major issue confronting physicians in everyday clinical practice is the extent to which they have a duty to discuss CAM therapies with their patients. Kerridge and McPhee’s article (page 164) argues that, in Australia, physicians have a “proactive and reactive” duty to do so.4 In the US, as part of the legal and ethical obligation of informed consent, physicians have a duty to disclose and discuss reasonable and feasible treatment alternatives, together with the risks and benefits of each option.2,3 While no court has yet held a physician liable for failure to disclose a CAM option, such a rule would be the logical extension of a 1993 federal appeals court case involving a patient’s claim that the physician should have disclosed the possibility of trying EDTA chelation therapy rather than bypass surgery to treat a carotid artery. The court stated that disclosure of such a therapeutic alternative would be required if the CAM therapy in question were generally accepted within the medical community.5 The question of liability connected with referring patients to CAM providers has also been of concern within the US medical community. In the US, mere referral to a medical specialist does not generate malpractice liability for the specialist’s negligence; similarly, mere referral to a CAM provider should not leave the referring physician liable for subsequent negligence by that provider.6,7 There are, however, a number of potentially applicable exceptions to this rule. The first involves delay of necessary medical treatment, resulting in patient harm.6,7 The second involves referral to a CAM provider that the referring physician knew or “should have known” might be “incompetent” (this rule suggests an obligation of due diligence in vetting both the provider’s credentials and, through reasonable inquiry, the provider’s general competence, skill, and practice).6,7 A third exception involves “joint treatment” of the patient, a fairly ambiguous term that could conceivably encompass situations in which the physician and CAM provider share information by telephone or email as part of the treatment plan.2,8 The possibility of such shared liability suggests exercising great care in selecting CAM providers to whom one will refer, and moving from a posture of distance from the CAM provider to one of closeness, in the hope of gaining a clear clinical understanding of the potential contribution — and risks — of the CAM therapeutic route and/or its interaction with conventional care. Licensure and credentiallingA second issue of concern to physicians in everyday clinical practice is understanding the legal authority that CAM providers have to deliver healthcare services. In the US, healthcare licensure is a matter of state law. Thus, there is great diversity among the states as to who can be licensed, and the scope of practice authority allocated to each class of provider by the licensing laws in each state. Across the US, the four professional groups which are licensed in most states are chiropractors (every state), practitioners of acupuncture and traditional oriental medicine (over 40 states), massage therapists (over 30 states), and naturopathic physicians (about 12 states).9,10 The numbers vary depending on what legal authority one counts as licensure to practise. For example, different forms of licensure include mandatory licensure, title licensure, mere registration, and combinations of these. In addition, a number of states allow a wide variety of unlicensed CAM providers to practise under certain circumstances.11 Further, compared with the limited scope of practice allocated by licensing laws to both allied health professionals (such as nurses and physical therapists) and CAM providers (such as chiropractors and acupuncturists), physicians in the US have an “unlimited” scope of practice, which means they can generally use all methods that their profession generally accepts as safe and effective to treat a given disease.1 However, there are several caveats. When physicians practise CAM therapies such as acupuncture, they must be properly trained and appropriately credentialled (although such training and credentialling requirements tend to be far less extensive than for non-physician acupuncturists);6,10 and, if they provide the patient with CAM therapies that are unsafe and ineffective, they are likely to be sued for medical malpractice and be disciplined by the state medical board.1,6 Ethical considerationsWhether or not liability results, physicians may find, at times, that their beliefs and commitment to the kind of evidence-based practice they practise in conventional care conflicts with patient interest in some CAM therapies. One useful approach to help negotiate such conflicts involves balancing the major bioethical principles (eg, non-maleficence, autonomy, beneficence, and justice) on a case-by-case basis,12 bearing in mind that shared decision-making is preferred to the older, more authoritarian model in which doctors simply disclose options without engaging patients in negotiated conversations.13 Thus, there may be a trade-off between granting the physician’s desire to avoid all harm to the patient (expressing non-maleficence), and honouring the patient’s persistent desire to try a CAM therapy for a time (expressing an autonomy interest) while continuing conventional monitoring.1,6,13 A slightly more sophisticated approach involves balancing seven factors (Box), to draw an appropriate ethical conclusion about the best course of action. This framework somewhat parallels the analysis of liability considerations in the US.6,13 For example, consider the following two cases taken from clinical practice. The patient has a premalignant condition that can be completely cured through surgery, but, if left untreated, can progress to invasive cancer. The patient tells her MD that she plans to pursue meditation, colonics and yoga, and to work with her Reiki master, rather than have surgery.13 The patient, a woman with recurrent metastatic ovarian adenocarcinoma, asks her oncologist to provide her with conventional treatment, but to be open to evaluating and guiding her regarding available CAM therapies.13 In the first case, the patient’s illness can be cured with conventional, although invasive, treatment (surgery); the evidence for CAM is low, but the patient understands and accepts the risks, and insists on trying CAM therapies. It would be ethical for the physician to allow the patient to try her regimen of CAM therapies, as long as she continues to monitor her condition conventionally.13 If the risk of cancer increases past a tolerable threshold, the physician should intensify attempts to persuade the patient that it is time to return to conventional methods of treatment.13 In the second case, the clinician should be aware of pertinent evidence and be willing to consider any intervention (CAM or allopathic) that has an acceptable risk–benefit balance.13 Whatever approach is used, physicians are still learning ways to fruitfully discuss integration of CAM therapies with their patients, as differing value systems and bases of knowledge about these therapies may leave a gap that only skilful negotiation can bridge.14 In this respect, the question is less about legal rules alone and more about relationship, conversation, and how the law may help or hinder these. The way forward for Australian legislators, judges and policymakers, as for their US and international counterparts, involves focusing not only on preventing negligence and fraud, but also on finding ways to facilitate therapeutic exchanges between a variety of healthcare providers and their patients.8 Framed in this light, the need for international dialogue around common legal and ethical issues pertinent to CAM therapies becomes ever clearer. Framework of considerations for drawing ethical conclusions Severity and acuteness of illness Curability with conventional treatment Invasiveness, toxicities, and side effects of conventional treatment Quality of evidence of safety and efficacy of the CAM treatment Degree of understanding of the risks and benefits of conventional and CAM treatments Knowledge and voluntary acceptance of those risks by the patient Persistence of patient’s intention to use CAM treatment

Michael H Cohen JD

To focus solely on reducing error may inadvertently reduce the quality of care In this issue of the Journal, Wenck and Johnston (page 117) describe the response of a medical indemnity insurer to the potential for claims associated with the contraceptive implant Implanon (Organon).1 The article stimulates reflection on whether the recent increased emphasis on risk management has been at the expense of quality assurance. The “quality movement” began in Australia over 30 years ago. The 1970s and 1980s saw the development of hospital accreditation through the Australian Council of Hospital Standards (now the Australian Council of Health Care Standards [ACHS], www.achs.org.au) and drove the system of credentialling medical staff in hospitals and delineating their clinical privileges that has become the norm. Accreditation of general practices resulted largely from the Australian government’s decision in the late 1990s to tie various government general-practice payments to accreditation. The “safety movement” developed more recently, catalysed in part in Australia by the 1995 report in this Journal of the Quality in Australian Health Care Study,2 and internationally by the report of the Bristol Inquiry3 and the US Institute of Medicine’s article To err is human.4 However, the increased momentum of the safety movement brings with it the risk that “risk management” (avoiding error) will overshadow “quality assurance” (enhancing quality). Further, Wenck and Johnston’s report raises the question of whether the prudential risk management outlined simply imposed financial disincentives to the continued use of Implanon, and increased funding for potential future claims. Or did it stimulate reduced error — clinical risk management? Recently, concern at the escalating cost of public liability insurance in general, and medical indemnity insurance in particular, has stimulated: A wave of tort law reform across Australia. An early reform that directly affected medical accident compensation, and hence medical indemnity costs, was the New South Wales Health Care Liability Act (2001). Reform of the medical indemnity industry. This culminated in Federal Parliament passing the Medical Indemnity (Prudential Supervision and Products Standards) Act (2003) and a number of subsequent bills. Over $300 million in federal subsidies for medical indemnity insurance premiums (the “Premium Support Scheme”) and medical negligence claims (the “High Claims” and “Exceptional Claims” schemes). Over $300 million in federal funding for the UMP (United Medical Protection) Support Scheme, which replaced the IBNRs (“Incurred but not reported” liabilities) Levy Scheme announced in 2002; the Commonwealth will now directly subsidise three-quarters of the IBNRs of doctors who were members of UMP at 30 June 2000. Now that medical indemnity is not directly provided by the medical defence organisations (MDOs), but by the subsidiary insurance companies they registered (“captive” insurers), the quid pro quo demanded by Government for the $600 million “rescue” injection of subsidies was: that the parent MDO or its subsidiary medical indemnity insurer provide enhanced programs of clinical risk management for their clients and that those clients participate in the programs offered, and that the medical indemnity insurers practise much higher standards of prudential risk management than did their MDO parents in the past. (Prudential risk management refers to how insurers set premiums and manage their reserves and business risk to ensure they remain solvent and able to meet liabilities as and when they arise.) In this process, the two meanings of the phrase “risk management” — the prudential risk management of the insurer, and the clinical/medicolegal risk-management services they offer those who are insured — became blurred. The article by Wenck and Johnston highlights the similarities and differences between these two forms of risk management. Prudential risk management can have perverse effects on clinical practice. For example, from around 1990, the MDOs moved away from “mutual” subscriptions (all doctors paid the same) to “differential” subscriptions (higher-risk disciplines paid higher rates). One result was that general practitioner and specialist obstetricians who practised low-volume obstetrics found a powerful reason to cease midwifery: the extra cost of obstetric indemnity far exceeded the income they derived from obstetric work. There were other factors as well, but the number of doctors for whose obstetric services rebates were claimed through Medicare dropped by 29% between 1989 and 1995.5 The sudden spate of claims arising from the use of the implantable contraceptive Implanon saw the MDOs respond in different ways. Prudentially, they needed to ensure that Implanon claims were properly funded. Clinically, they wanted to reduce the number of such claims by encouraging safe use. Some MDOs chose to maintain the status quo — perhaps relying on media reports either to deter doctors from using Implanon or to ensure they reviewed their clinical techniques. Other MDOs, such as MDA National and UMP, moved coverage for matters arising from Implanon use into the more costly “procedural general practice” category of insurance. The latter approach would predictably lead to most non-procedural GPs stopping use of Implanon in their clinical practice. Who would pay up to $10 000 more per year for insurance to cover a procedure they might perform 20–30 times a year for a fee of less than $30 per service? A third approach was adopted by the Medical Defence Association of Victoria (MDAV) in July 2003,6 demonstrating that risk management by an MDO can be vigorous without perversely affecting clinical services. GPs who used Implanon were advised that they might be asked to pay an excess of $5000 if they were unable to demonstrate adequate training and technique should an Implanon claim be brought against them. There was no fixed economic deterrent to using Implanon, but there was an incentive to “risk manage” clinically to avoid the $5000 excess. After monitoring claims in the ensuing period, MDAV announced in May 2004 that the excess would no longer be applied.7 Similarly, United Medical Protection announced on 21 May 2004 that Implanon insertion would revert to being covered in the non-procedural general practice category of insurance, but with ongoing conditions. To quote from UMP’s media release: It will be a condition of cover that members agree to adhere to risk management guidelines based upon the RACGP’s [Royal Australian College of General Practitioners’] guidelines . . . Members using Implanon will be required to undergo a training session in patient selection and counseling and Implanon insertion and removal techniques arranged by the manufacturer Organon. In addition, members will need to perform the first six insertions under the supervision of a medical practitioner experienced in Implanon insertion.8 MDA National had earlier announced, on 25 February 2004, that, with effect from the insurance year commencing 1 July 2004, Implanon cover would be available again in the non-procedural category — subject to adherence to risk-management guidelines.9 Some MDOs now offer premium discounts to members who satisfy specified standards for risk management in their practices or attend risk-management educational seminars and similar activities. I recently reviewed well over a thousand of the applications for MDAV’s RISQ (Risk Identification for Sustaining Quality) program. Some applicants supported the program strongly, saying the application process stimulated a major review of their practice’s policies. Others thought the discount was not worth the time required to complete the application. In my opinion, this latter group missed the point. The premium discount is a relatively minor immediate incentive when compared with the ameliorative effect that effective risk management may have on claims frequency, and hence the potential impact on their future premiums. Further, one member made another, poignant point: I know this is a very worthwhile exercise, but it’s had the effect of making me view every patient as a potential plaintiff. While his comment strikes an empathic chord, he also missed the point. Medical practice requires quality assurance and risk management. It also requires organisational governance — management of personnel, financial efficiency, systems efficiency, and so on — as much as clinical governance. All the various components of practice governance need to be managed. Focusing on any one component to the detriment of the others leads to a mismanaged practice. It is not a choice between risk management or quality assurance, we need both — less error is part of better quality. Saxe’s poem about the blind men and the elephant is apposite.10 Six blind men argue vigorously about the nature of the beast of which each is holding one part — the tusk, the trunk, an ear, a leg, and so on. The poem concludes: So oft in theologic wars, The disputants, I ween, Rail on in utter ignorance Of what each other mean, And prate about an Elephant Not one of them has seen! The elephant is clinical governance (continuous quality improvement). It has many parts. All must be subject to equal focus.

Paul Nisselle AM, FRACGP

The contraceptive implant Implanon (Organon) was introduced in Australia in May 2001, and in the next 18 months was associated with an unprecedented number of adverse incident reports to medical indemnity insurers, including almost 100 unintended pregnancies. The medical indemnity insurer, MDA National, responded to this by applying the Australian and New Zealand Standard for Risk Management (AS/NZS 4360: 1999) in two stages. The first stage was to contain potential costs by moving the treatment into the general practice procedural category, resulting in a one-year moratorium on its use for most general practitioner members (prudential risk management). The second stage was to manage the clinical risk by developing strategies to reduce identified risks associated with the procedure. The Royal Australian College of General Practitioners (RACGP) was enlisted to develop guidelines for use of Implanon, with a consent form and checklists for doctors and patients, enabling MDA National to reinstate the treatment to the general practice non-procedural category. This case demonstrates the need for early risk assessment and development of risk-management tools for new treatments and devices, a role that is appropriate for the RACGP.

Beres C A Wenck MBBS, FAMA · Penelope J Johnston

Attempted repair of human spinal cord injury by transplantation of stem cells depends on complex biological interactions between the host and graft. Extrapolating results from experimental therapy in animals to humans with spinal cord injury requires great caution. There is great pressure on surgeons to transplant stem cells into humans with spinal cord injury. However, as the efficacy of and exact indications for this therapy are still uncertain, and morbidity (such as rejection or late tumour development) may result, only carefully designed studies based on sound experimental work which attempts to eliminate placebo effects should proceed. Premature application of stem cell transplantation in humans with spinal cord injury should be discouraged.

Jeffrey V Rosenfeld MS, FRACS · Grant R Gillett PhD, FRACS

Rebuilding trust in healthcare. Jamie Harrison, Rob Innes, Tim van Zwanenberg (editors). Oxon: Radcliffe Medical Press, 2003 (ix + 198 pp). ISBN 1 85775 938 9. The essays in this book were written in the aftermath of the Bristol paediatric cardiac surgery debacle, the Alder Hay scandal (over the use of dead children’s organs) and the Shipman murders. In the foreword, Rabbi Julia Newburger, Chief Executive of the King’s Fund in London, explains that, despite this context, the overall message goes far beyond calling for more accountability measures for healthcare. Other contributors reinforce her challenge. They are calling for a cultural change — one of leadership within medicine and within management. This leadership needs to take up where government leadership finds it increasingly hard to deliver. The 15 contributors include journalists, psychologists, sociologists and ministers of religion, as well as clinicians. The difference between accountability (witness the plethora of “quality committees” mushrooming in our hospitals) and trust is the underlying theme. We are warned that increasing focus on system audit may not bolster the public’s confidence. It is the insistence on professional integrity and the restoration of earned trust that will promote cultural change and bring back confidence in the healthcare system. I highly recommend this book to all clinician and management leaders. It is a powerful, challenging and exciting collection of essays by a variety of individuals, all of whom are deeply concerned by the present breakdown of trust in our healthcare system. Kerry J GoulstonChair NSW Greater Metropolitan Transition Taskforce North Ryde, NSW

Kerry J Goulston

Non-compliance with treatment of pulmonary tuberculosis (TB) by an individual can put the community at risk of transmission of TB. Public health (detention) orders can be issued to detain non-compliant individuals, but this is a last resort and rarely used. Two recent cases in New South Wales illustrate the process of issuing a public health order in NSW, and some of the issues that may arise. The NSW law can also be applied to patients with severe acute respiratory syndrome (SARS) or HIV/AIDS. The other states and territories have similar laws, which often apply to a broader range of diseases and have fewer limits on issuing and extending orders.

Sanjaya N Senanayake FRACP, MB BS(Hons), BSc(Med) · Mark J Ferson MD, FRACP, FAFPHM

Everyone knows medical research is about improving healthcare Recently I had some trouble with people one might call “pseudoscientists”. These individuals are often technically quite competent; they seem to know their craft and they produce seemingly good work. But there is something amiss. It took me a long time to find out what that might be. Now I think I have identified it — the pseudoscientist has entered the field of science for the wrong reason: to advance not medicine, but himself. This theme must have been on my mind the other night, when I had the most vivid dream. The dream took me to the “Annual Festival of Pseudoscience”, where a panel of the most distinguished pseudoscientists reached consensus on how to become a fellow pseudoscientist. Here are the 10 commandments of pseudoscience that they dictated to their audience. Ensure that passionate belief rather than reason is the force that drives you. In science, one tests (more accurately, falsifies) hypotheses. In pseudoscience you want to “prove” what you already “know”. Only the biased researcher can mislead the world effectively. Avoid scientific training. Pseudoscience needs enthusiastic amateurs who have picked up the rules of science while busy doing other things. The worst that could happen to pseudoscience is for properly trained career scientists to join its arena. Maintain your bias. Bias usually originates from interests that create financial, personal or emotional conflicts. Nurture those interests and never disclose these conflicts to anyone, particularly not when publishing. Use publicity to obtain funding. Research funds are becoming scarcer by the minute. Lack of funds can seriously delay your endeavours. If you find it difficult to compete, the time-tested approach is to make more noise than anyone else. Hire a PR firm, for instance. Once the daily papers regularly sing your praises, your pseudoscience will thrive. Do not lose sight of what you intend to prove. Some people say that good research can never be “negative” — even showing that therapy X is not effective would yield the positive result of enabling patients to choose something that does work. Make sure your goals are not obscured by such old-fashioned nonsense — your aim as a pseudoscientist is to assist your friends, the manufacturers or promoters of therapy X. Let your goals drive your data analysis. Even with safeguards in place, you might one day generate a result that does not fit your preconceived ideas (or those of your sponsors). Subanalyse and subanalyse until you have what you were fishing for — a significant result showing what you want. Suppress unwelcome results. If things should go disastrously wrong and even extensive data dredging does not yield the desired outcome, the professional pseudoscientist must resort to the last, desperate, but usually effective, measure. Make the unwelcome finding disappear — don’t ever publish anything that does not confirm your beliefs or that might upset your friends. Overinterpret. More often than not, you will create data that you and your sponsors like. Now you must ruthlessly overinterpret these findings to ensure that everyone knows about your work. Publish your results as often as you possibly can. Journal editors don’t like duplicate publications, so it would be foolish to tell them. Attack opposing scientists. There is always a danger that scientists will publish papers that upset pseudoscientists. In such cases, initiate a campaign of defamation against your opponent — this will decrease their credibility and increase yours, and all will be fine again. At this point, I woke up feeling sick and anxious. Where does the dream end and reality begin? Did I have a nightmare or a vision? And, horror of horrors, did I not recognise some of the faces of the panellists? But it must have been a nightmare! These 10 commandments are just a guide on “how not to conduct medical research”. Surely, medical research is not abused as a career springboard? This would result in chaos and lead us badly astray without a compass for orientation. Surely, any responsible researcher knows that medical research is about improving healthcare? If not, how could we continue with the progress medicine has made so far? Surely, medical research has not been taken over by pseudoscientists. Or has it?

Edzard Ernst MD, PhD, FRCP

Restoring humane values to medicine. A Miles Little reader. Ian Kerridge, Christopher Jordens, Emma-Jane Sayers (editors). Sydney: Desert Pea Press, 2003 (x + 307 pp). ISBN 1 87686 108 8. Miles Little’s distinguished credentials and past experience as a surgeon, poet, philosopher and humanist make him particularly qualified to address the restoration of humane values to medicine. The origin of threats to values in medicine today is addressed in depth and in an analytic and reflective way. His essays are well chosen to accomplish this, but are difficult to read, as the language at times seems purposefully abstruse. Nonetheless, the importance of the topics covered makes the effort worthwhile. The technique of adding commentaries by thoughtful people in the field is helpful in putting Little’s views in perspective and in a contemporary context. One of the unique contributions to the book is Little’s discussion of the ethics of surgery and the analysis of its five moral domains. These follow the progression of the surgeon–patient relationship through the process of surgery and the patient’s response to each stage. As Russell Gruen points out in his associated commentary, they “help us to understand why surgery cannot be practised as a purely technical exercise.” In medicine, which is increasingly technology-dependent, the promotion of humanism in physicians and surgeons must be a strong antidote to the impersonalisation and deprofessionalisation which technology can bring. The other essays address the conflicts and dilemmas facing the practitioner in contemporary medicine. As one reads each essay there is an opportunity to reflect and gain a better understanding of the issues, whether the subject is euthanasia, death, the place of evidence-based medicine and epidemiology, the real issues of consent and whether it can be informed, the impact of resource restraints, or the demand for accounting logic in medicine leading to “ethonomics.” Physicians need to reflect on these issues if they are to bring care, compassion, and integrity to their practices. These essays are particularly useful to those in academic medicine where the teaching of the physician as healer and professional require humanism and reflection if these qualities are to be imparted. Sylvia R CruessAssociate Professor of Medicine McGill University, Montreal, Canada

Sylvia R Cruess

Malcolm H Parker Associate Professor of Medical Ethics, School of Medicine, University of Queensland, Herston Road, Herston, QLD 4006. m.parkerATuq.edu.au To the Editor: Gerber1 appears sympathetic to the following reasons for rejecting damages in cases of wrongful birth, quoted from the High Court minority in Cattanach v Melchior,2 and judges in similar cases: doctors do not owe a duty of care that protects the economic interests of patients; the birth of a healthy child should not be regarded as a legal harm, because the birth of a healthy child is a good thing, the cost of rearing a child does not exceed the value of parenthood, and parents ought not to enjoy the advantages of parenthood without the concomitant responsibilities; awarding damages would indicate to the child that he or she was unwanted; and doctors should not be liable for most of the costs of rearing a child, because parents have a choice of rearing the child or surrendering it for adoption. As to the first point, why should doctors be exempt from any loss that results from their negligence? Depicting this duty as one of “protecting economic interests” distorts the nature of the duty of care, which requires the duty holder to avoid foreseeable damage, which includes economic loss consequent on the negligence. Regarding the second point, balancing the costs of rearing the child against the value and advantages of parenthood is conceptually misleading. The implication is that the value of parenthood should render the costs of rearing the child relatively trivial. A more coherent interpretation is that, because the costs of rearing the child and the value of parenthood are incommensurable, the natural love for the child and the value of parenting that follow the birth ought not discount the damage. This interpretation also informs responses to the third and fourth points. Not wanting another child, and not wanting the particular child once it exists, are distinct concepts. The idea that Jordan Melchior was not wanted at the time his parents took steps to avoid further pregnancies is incoherent. Wanting to avoid further pregnancies and wanting to nurture the child who is born are perfectly consistent positions, whether the case involves forgotten contraception or negligent sterilisation. Finally, the idea that, because they have the choice to keep or surrender the child, the parents should bear the costs if they keep it suggests that, once born, the particular child can be regarded as a commodity — something that the general position against awarding damages for wrongful birth repeatedly disavows. One of the judges quoted by Gerber claimed that such children would come to think of themselves as unwanted, and that this was “obscene”. The same judge’s glib claim that the parents can choose to keep or surrender the child strikes me as the obscenity.

Malcolm H Parker

Paul Gerber Honorary Reader in Legal Medicine, University of Queensland, Brisbane, QLD. In reply: Parker’s letter does little more than repeat the arguments that found favour with the majority in the High Court. He approaches the issues raised by this controversial litigation from an ethical perspective. Alas, the parents’ claim for the cost of raising a healthy child, conceived as a result of the alleged negligence of the defendant gynaecologist, raises the legal issue of restitution: does the law of tort recognise this head of damages as a “loss” for which parents may be compensated? Courts have, in the past, answered this question by reference to general principles based upon legal values. In the Melchior case,1 the majority departed from that hallowed principle. So be it. Does that make Jordan Melchior a “commodity”, having a commercial value? Yes! The plaintiffs faced the choice of either keeping their son, or mitigating their “loss” by placing him for adoption. They chose the former. Priestley JA had, in an earlier case, put the issue succinctly: “After that decision was made, the defendant was not legally responsible for the parents’ financial cost of rearing the child”2 (this was restated by Kirby J in the Melchior case1). Parker may not like it, but the law of tort has — up till now — shown more caution in awarding damages for what is called pure economic loss (ie, loss affecting purely financial interests) than it has in relation to conduct that causes damage to person or property. Before the Melchior case, that distinction had been firmly embedded in the law of tort and formed the basis of established rules governing liability for damages.3 That distinction has now been blurred by placing a financial value on the parent–child relationship.

Paul Gerber

There is evidence that drug-marketing techniques affect doctors’ prescribing practices. This has ethical implications for doctors, as it affects the trust required in the doctor–patient relationship. Doctors need to recognise they are affected by drug marketing, and take steps to maintain their independence from the pharmaceutical industry. At a time when leaders of the medical profession in Europe and North America are calling for a critical re-evaluation of how the medical profession “dances with the porcupine”1 of the pharmaceutical industry2-6 it is disappointing that leaders of the profession in Australia appear in denial about the influence of the industry on such things as the prescribing patterns of doctors, the clinical research agenda, and bias in the publication of pharmaceutical research findings.7-9 The most striking denial is that of the effect of pharmaceutical promotion of various kinds on the prescribing practices of doctors. 8,9 Here I wish to: acknowledge that the issues surrounding the relations between the medical profession and industry are not unidimensional; draw attention to the overwhelming evidence that our prescribing habits are open to industry influence; remind doctors of the key ethical issues which are at stake; and offer pragmatic suggestions for finding ways of reducing the dependence of the medical profession on support from the industry. As remarked by an industry executive 40 years ago,10 the medical profession must look at its own conduct and not place responsibility on the pharmaceutical industry. Within the pharmaceutical industry, at least two independent sections interact with doctors and the healthcare system: the drug development/research section, and the drug promotion/advertising section. The former has made major contributions to health improvements in the developed world, and its role is more comfortably acknowledged by doctors than is the drug promotion section. More than half the biomedical research being done in the United States is now privately funded, with sponsors able to set the research agenda.4 The pharmaceutical industry has learnt to influence our prescribing behaviour indirectly, and uses “opinion leaders” from within the profession to promote its products and to help identify its research agenda. 11,12 There is also clear evidence of publication bias, selective publication and selective reporting of sponsored clinical trials. 3,13 However, I do not want to explore these and other important research-related issues here. Rather, I will focus on the very strong evidence regarding the effectiveness of industry activities on prescribing practices (Box). In identifying this compelling evidence, I accept that the pharmaceutical industry mostly consists of public companies with legally mandated responsibilities to shareholders and legitimate rights to promote their products. My criticism is of the naïveté of doctors and/or their unwillingness to accept overwhelming evidence that the techniques used by the industry to increase prescribing of their products actually work. Doctors interact with the pharmaceutical industry in various ways. Most common are direct face-to-face visits from company representatives (referred to as “drug reps” rather than “sales reps”). Also common are indirect interactions via a wide range of marketing techniques, including direct mailing, advertising in medical journals and medical newspapers, and sponsorship of medical conferences and medical products (such as computer software). For a smaller proportion of the profession, the interactions may be through involvement in clinical trials or in industry advisory groups, speakers’ panels and the like. Although only a select few play these latter roles, they are greatly valued by the pharmaceutical industry as “opinion leaders” in shaping the views of the rest of the profession, especially for new medications. 11,12 In addition to drug promotion, the industry seeks to alter our prescribing patterns by other means. These include “illness promotion” (using public awareness campaigns in the general media to encourage more people to seek new treatments) and support for patient-help organisations (again indirectly encouraging more patients to present to doctors identifying either their ailment or its desired drug treatment). 2,17-19 There is nothing inherently improper about any of these interactions, provided that the medical profession, collectively and individually, is fully and openly aware of the effect of the interactions, that all such interactions are transparent to the community, and that doctors are capable of negating any undesirable effects on their prescribing habits. At present, none of these provisions are being met. The ethical issues at stake here for most practising clinicians are simple to identify but complex to resolve. To be a medical “professional” implies that patients can rely upon the independence and trustworthiness of any advice or treatment proffered.20 It is a significant ethical failing to aspire to such independence and to the respect and trust that underpin an effective doctor–patient relationship while wilfully or ignorantly denying the evidence that the pharmaceutical industry does affect our prescribing behaviour. The impropriety of this stance is compounded by information asymmetry (where the patient is almost always dependent upon the doctor for information and guidance about medications) and by the fact that the prescribed drugs are usually subsidised by public funds.16 Most doctors seem to genuinely perceive they are immune to such influences, seeing themselves as acting only on the best available evidence in the interests of their patients.14 To change this perception, a new and systematic approach to these ethical issues is warranted. These issues are not new, but their significance has increased in parallel with the growth of the size, power and influence of the pharmaceutical industry. The medical profession needs to confront these issues before a concerned public forces us to do so. The pharmaceutical industry has had sufficient awareness of public opinion to see the need to strengthen its code;21 surely the medical profession might also have the initiative to re-examine its performance in this area? If we agree that these are significant ethical issues, what practical steps can the profession, and the institutions and healthcare structures in which we work, take to maintain community trust? Several writers have proposed a range of suggestions. 5,6,14,16,22 Ideas of special relevance include the Australian website that critically monitors drug advertising (www.healthyskepticism.org/adwatch.asp)10 and the American Medical Student Association’s campaign “PharmFree”, which is based on another US initiative, “No Free Lunch”.5 Apart from doctors choosing not to see pharmaceutical company representatives (a very simple step which I took a decade ago), readily achievable steps include adoption of policies by hospitals, colleges and professional associations to make those organisations and their staff or members more independent of the industry. Such policies might include: funding directly (from hospital budgets and doctors’ contributions) the catering and other facilities needed to promote continuing education of staff, more especially, but not solely, the education programs provided for junior doctors; taking formal, publicly announced decisions to reduce financial reliance on the pharmaceutical industry in all areas; and developing and policing procedures for identifying and dealing with conflicts of interest for staff and the organisation in regard to the use of pharmaceutical industry support. In addition, our medical school faculties and medical colleges must ensure that the ethical issues surrounding relationships with the pharmaceutical industry are included in medical student and postgraduate training programs, and that knowledge and attitudes of students and trainees to the industry are included in formal assessment. As the World Medical Association has reviewed its code of conduct about relationships with the industry,23 so too our responsible bodies (medical boards, medical colleges and professional associations) should critically review their codes and take whatever steps are available to them to enforce these codes. It is surely time for leaders of the profession to truly open their eyes to these issues. Some of the available evidence about doctors’ prescribing habits Most doctors deny that gifts from the industry influence their prescribing.14 The number of gifts received correlates with the belief that seeing representatives does not influence prescribing.14 80%–95% of doctors see industry representatives regularly.4 More frequent contact is linked to unnecessary prescribing and to increased use of new drugs. 14,15 Attendance at sponsored conferences is associated with increased prescribing of the sponsor’s product. This increase can be seen for the next 6 months.14 It is estimated that industry spends about $21 000 per year per practising doctor on drug promotion.16

Kerry J Breen MB BS, MD, FRACP

Little research has been done on the extent of the relationship between the pharmaceutical industry and medical students, and the effect on students of receiving gifts. Potential harms to patients are documented elsewhere; we focus on potential harms to students. Students who receive gifts may believe that they are receiving something for nothing, contributing to a sense of entitlement that is not in the best interests of their moral development as doctors. Alternatively, students may be subject to recognised or unrecognised reciprocal obligations that potentially influence their decision making. Medical educators have a duty of care to protect students from influence by pharmaceutical companies.

Wendy A Rogers PhD, FRACGP · Peter R Mansfield BMBS · Annette J Braunack-Mayer BMedSci(Hons), PhD · Jon N Jureidini MB BS, PhD

To quote from Rogers’s article in this issue of the Journal, “There is growing debate about the ethics of relationships between the pharmaceutical industry and the medical profession”.1 Nothing could be more true. However, if this debate is raging for doctors, then it is sizzling for medical students. While doctors might not have the time or the inclination to voice their opinions on the pharmaceutical industry publicly, Australian medical students seem to have both. The relationship between medical students and the pharmaceutical industry has been hotly debated by the National Council of the Australian Medical Students’ Association (AMSA) for years. Yet tangible outcomes and policy have been less palpable, evidence of just how complex this issue is. Medicines Australia has imposed self-regulation upon the industry through its own code of conduct (www.medicinesaustralia.com.au). This is an important document in various ways, but, most importantly, it sets practical boundaries within which the industry can ethically operate. So why should medical students bother tackling this issue? We don’t have script pads or the status to influence prescribing habits of those who do. Furthermore, with so many codes of conduct floating around, surely we fall under these somewhere? Surprisingly not. Medical students appear to occupy a loophole in an otherwise highly regulated environment. Codes commonly use the terms “medical professional” (health professionals who are unable to prescribe [eg, nurses]) and “non-prescriber” (people without degrees in health fields and who are unable to prescribe), but do not mention medical students. As students, and thus non-prescribers, we sit outside these codes, yet we will prescribe in years to come. For this reason, AMSA is taking proactive steps to formulate policy and produce its own code of conduct for medical students. At the recent meeting (Adelaide, 12–15 March 2004) of the AMSA National Council (which comprises one elected representative from each of the 12 medical schools in Australia), various speakers were invited to give the full spectrum of opinions on the topic. These guest speakers included a physician and a professor of clinical pharmacology, along with representatives from Medicines Australia, a pharmaceutical company and Healthy Skepticism. After several very informative presentations, the AMSA Council met in private to discuss the best way forward. Feedback from the Council varied greatly, but it was decided that AMSA’s main responsibility at this stage is to educate medical students about the differing opinions on this controversial issue. Following this education campaign, a nationwide survey will be conducted to gauge medical students’ opinions at the grass roots. Data from this survey will then be used, with assistance from the AMSA Council, to formulate policy and a code of conduct. Although not binding, this code of conduct will act as a practical guide for medical students and their societies. AMSA feels very strongly that, while individual opinions on this issue may vary greatly, our responsibility is, at the very least, to educate medical students about the pros and cons. In this way, medical students can make better-informed decisions about how far they take their relationships with the pharmaceutical industry.

Matthew S Hutchinson

Research into adolescent health issues is hampered by absolute requirements for parental consent. Society’s recognition of adolescents’ autonomy and decision-making capacity has been embodied in the legal recognition of the mature minor’s right to make decisions on matters affecting his or her life. Psychological research indicates that young people from 14 years have decision-making capacity. US and UK research ethics guidelines acknowledge the mature-minor principle, but Australian guidelines are out of step with international practice. An absolute requirement for parental consent in Australian research ethics guidelines is potentially unethical if it denies mature adolescents’ autonomy and is a barrier to participation, study validity and improved health outcomes through research findings. There are grounds for considering a mature-minor clause in the National Health and Medical Research Council research ethics guidelines, particularly in the context of youth participation in minimal-risk research.

Lena A Sanci MB BS, PhD, FRACGP · Susan M Sawyer MB BS, MD, FRACP · Penny J Weller BA/LLB, MA, PhD · Lyndal M Bond BA(Hons), MA, PhD · George C Patton MB BS, MD, FRANZCP

The South Australian Workers Compensation Tribunal has found that stress contributed to a man’s colorectal cancer. The medical evidence for this is very limited, and the case highlights the difference between scientific and legal proof. The South Australian Workers Compensation Tribunal has concluded, on the basis of the evidence presented to it, that workplace stress contributed to the development of colorectal cancer in a prison officer.1 This finding highlights the role of the adversarial legal system, in which courts and tribunals are generally limited by the material the parties choose to present.2 However, this subtlety was not reflected in the subsequent media coverage, with headlines such as “Work and stress — judge finds a deathly link” and lines such as “A judge has accepted that a prison officer’s job stress contributed to the cancer that killed him in a ruling that threatens to unleash a series of cases . . .”.3 It is therefore pertinent to review the medical history on which the decision was based and the medical literature to see whether this putative link should be challenged, despite the lack of an appeal by the South Australian Crown Solicitor’s Office.3 Medical historyThe prison officer was employed by the South Australian Department of Correctional Services for 21 years, from 1977 to 1998. A diagnosis of colorectal cancer, resulting in resection of an advanced colon cancer of the caecum (Dukes’ C stage), was made at age 59 years, and the man died in 1998 aged 60 years. The prison officer’s father had died of colorectal cancer when 75 years old, with age at onset of his cancer unknown. The Tribunal noted the influence of inheritance in the development of colorectal cancer, but several factors invite comment. First, there is no indication whether a detailed family history had been obtained, for example by a family cancer service. It is well documented that history-taking by individual practitioners misses a substantial number of relatives affected by cancer.4,5 Moreover, the decision does not indicate whether the cancer tissue was submitted for genetic testing, which could provide objective evidence of inherited risk through immunohistochemistry and microsatellite instability testing.6 Medical literature reviewThe Tribunal described the “considerable examination of relevant literature” by the various medical experts as a key dimension of the case.1 Four main studies were cited.7-10 One study compared 551 individuals with colorectal cancer with 1861 controls.7 The authors concluded that “logistic analysis yielded hypotheses for colon cancer risk in males with potentially high exposure to solvents, abrasives and fuel oil and in those in jobs with . . . high stress”.7 A study by Courtney et al, involving 569 cases and 510 controls, revealed a strong association between a history of work-related problems and colorectal cancer.8 The odds ratio was 5.5 (95% CI, 2.3–23.5). The authors, explaining the wide confidence interval, stated that “because most of the events were relatively uncommon in this population, the estimates of effect were not precise”.8 Courtney et al subsequently reported another case–control study involving 774 pairs, again examining the relationship of job stress and risk for colon cancer.9 Participants in the highest-stress group had a slightly increased risk when compared with those in the lowest-stress group (odds ratio, 1.3; 95% CI, 1.0–1.6), but there was no evidence of a trend. The authors concluded that “if job stress, as reflected by perceived job demand or control, is a determinant of colon cancer, it is probably not a strong one”.9 The applicant for compensation (the prison officer’s widow) also relied on a study by Kune et al of 715 patients with colorectal cancer and 727 controls (data from the Melbourne Colorectal Cancer Study).10 Work problems were found to be significantly more common for colorectal cancer patients. Although recall bias was not completely controlled for, it was thought that it was “probably not an important factor”.10 Other articles by Kune et al were not cited by the applicant or by the prison officer’s employer (the respondent).11,12 One of these papers used data from the Melbourne Colorectal Cancer Study to evaluate the effect of personality on risk of colorectal cancer in 637 individuals with colorectal cancer and 714 controls. Questions that tested a particular personality profile with regard to cancer risk revealed a significant association between a particular personality type and risk of colorectal cancer. With the caveat that the results should be cautiously interpreted, Kune et al concluded that the data were consistent with the hypothesis that “personality type may play a role in the clinical expression of colorectal cancer”.11 Yet further data from the same study revealed that significant protection against colorectal cancer was associated with self-reported “religiousness”.12 How these findings might have affected the Tribunal’s decision is unknown. This selective use of data is a feature of the adversarial system in which “parties are not obliged to call all the relevant evidence . . . only that which favours their case”.2 Indeed, our review here may be similarly criticised for presenting further selective references. Although a comprehensive review of the factors that contribute to the occurrence and effective management of workplace stress exists,13 an objective and complete review of the medical literature with regard to stress and colorectal cancer has yet to be published. Other literature before the Tribunal included a review of evidence concerning any relationship between the mind and cancer.14 This review noted that “there is very limited evidence that either stress or depression are risk factors for the onset of cancer”. It concluded that: On balance, the findings suggest that some psychological factors probably do exert an influence on the onset and cause of cancer, but the extent of their influence is unknown. Clearly further research and replication studies are needed to clarify the nature of this relationship.14 Legal proofSamuels, writing in the Journal in 1998, provided a detailed outline of the differences between medical truth and legal proof. Commenting that the question to be answered in our adversarial legal system is not “What is the truth of the matter?”, Samuels conceded that “medicine is a science and law is not”.2 Causation in science has multiple defined criteria (such as strength and consistency of association, temporal association, specificity, dose–response relationship, known or theoretical mechanism and coherence of evidence).15 Causation in law has a different basis, being “determined as a matter of common sense”, so that an inference of causation in a legal sense may be drawn when the level of evidence may be insufficient for causation according to the scientific criteria described above.16 A medical fact is “one which can be empirically supported”, whereas a legal fact “is one which is more probable than other countervailing facts”.2 It appears from the Tribunal’s reasons for its decision that, whereas the respondent’s medical expert tried to use a scientific standard of proof in examining the evidence for a contribution of stress in cancer, the Tribunal was only concerned with the balance of probabilities. ConclusionTo date, the association between stress at work and colorectal cancer has been the subject of a limited number of conflicting and inconclusive studies. The decision made by the Tribunal turned on the medical and other evidence actually placed before it by the parties. In finding that on the balance of probabilities the prison officer’s employment contributed to his cancer, the Tribunal found it unnecessary to distinguish between causation and acceleration. Thus, the fundamental causation issue has not been subject to legal precedent. It will be of considerable interest to consider any further cases in which the question might again arise, especially in light of the then current state of relevant scientific evidence.

Allan D Spigelman FRACS, FRCS, MD · Peter Dwyer MSc(Soc), DipLaw, FACLM(Hon)

There are important distinctions to be made between the inquisitorial process of a tribunal, such as the South Australian Workers Compensation Tribunal, and the adversarial process of the courts. To quote the renowned English Law Lord, Lord Devlin: In the [adversarial process], the judge presides at the trial, directs the proceedings and rules on the law; he is not there to hold an inquiry. It is quite different from the [inquisitorial process] where witnesses are summoned by the court and examined by the judges, the role of counsel being to tender a witness, and ask supplementary questions.1 A tribunal is inquisitorial. It can ask its own questions of the witnesses called, and may have the capacity to commission its own expert advice and call its own witnesses. Often a tribunal has several people sitting on it; one is usually legally qualified, but others may be experts from the field that is the basis of the proceedings. Whereas claims for compensation for personal injuries arising out of a defendant’s negligence are brought in civil courts and determined by common law processes, in Australia the most common areas of injury — work- and transport-related accidents — are covered by “statutory” schemes. These are arrangements by which claims for compensation are assessed under specific legislation, rather than at common law. Many statutory workers’ compensation schemes were not established simply as narrowly defined insurance schemes, but were given flexibility to provide social benefits. For example, Lord Campbell’s Act,2 enacted in England in 1846, was intended to overthrow the ruling made under common law in 18083 that damages for the death of a human being could not be claimed by another person. The Act was passed to protect the widows and orphans of men killed in industrial accidents by providing, through statute, access to compensation for loss of the income of a bread winner — compensation that could not be obtained at common law. Many people would think that Mrs Simpson, the applicant in the case described by Spigelman,4 had a right to bring her claim for compensation for her husband’s death. That right does not exist at common law, but is provided by statute. In the courts, the claimant (civil) or the Crown (criminal) has the burden to prove its case, and the benefit of the doubt falls to the defendant. The major difference in the meaning of “doubt” between the criminal and civil courts is that, in a criminal court, the test is “beyond reasonable doubt”, a much tougher test than the civil court’s “on the balance of probabilities”. Simpson v South Australia (Department of Correctional Services) was heard in the South Australian Workers Compensation Tribunal, but the test was still “on the balance of probabilities”. The claimant in the Simpson case introduced medical evidence that it was a “common observation” (acknowledged not to be a proven scientific fact) that there was a link between stress and cancer. In most workers’ compensation schemes, compensation will be paid if work caused, aggravated or accelerated the injury — that is, either caused or was a “significant contributing factor” to the injury. The phrase “significant contributing factor” appears in much workers’ compensation legislation. It was defined in the Victorian County Court5 as meaning a factor whose contribution was “more than de minimis but less than a major or dominant factor”. Not a very high hurdle to jump! Paragraph 70 of Judge McCusker’s decision in the Simpson case underscores the test he applied: A careful examination of the material available in this case indicates, on the balance of probabilities [my emphasis], that the worker’s employment contributed to the cancer that caused his death. Doctors are often dismayed at the difference between the standard of proof required in civil cases (the balance of probabilities) and the medical/scientific standard. Many have the perception that judges (and tribunals) award compensation to claimants seen as needy — redistributive justice, in which money is taken from rich defendants (more specifically, their insurers) and given to the unfortunate. Therefore, many doctors would be dismayed at the Simpson judgment. Most would believe that any relationship between stress and cancer is at best tenuous, and certainly not proven to the standard required of science. They are also incensed when judges make decisions in intensely technical areas of medicine, saying that judges are no more qualified to decide purely medical issues than doctors are to decide legal issues. Most Australian states now adopt a different approach to resolving medical disputes raised in workers’ compensation claims. In South Australia, the medical issue was determined by the tribunal. In Victoria, Queensland and Western Australia, such disputes are resolved by referral to a multi-doctor medical panel or medical tribunal. Doctors are appointed to any one panel on the basis of the nature of the injury. For example, impairment arising from a back injury might be assessed by a panel consisting of an orthopaedic surgeon, a neurosurgeon, a psychiatrist and an occupational health physician. If the Simpson claim had been referred to a medical panel, the panel would probably have comprised a colorectal surgeon, a gastroenterologist, an oncologist and an immunologist, or similar, with acknowledged expertise in the area. These doctors would have used their existing knowledge, and would have viewed the expert opinions provided by the parties, critically analysed them, and checked the references cited, before forming a collective view. In contrast, the adversarial process encourages the use of medical “gladiators”, who are selected because their opinion advances the client’s cause. Multiple opinions, for and against, are put into evidence. This leaves judges (or juries) in the position of having to decide between competing schools of medical or scientific opinion. The most famous Australian example of the difficulty lay juries (and judges) experience when assessing expert evidence is the handling of the forensic evidence in Lindy Chamberlain’s trial for the murder of her baby, Azaria. The trial, held in the Supreme Court of the Northern Territory, resulted in Mrs Chamberlain being wrongly convicted of murder in 1982. Much of Judge McCusker’s judgment in the Simpson case is a critical analysis — by a lawyer (ie, the judge) — of the many medical opinions put into evidence by both the claimant and the defendant, leading to a final decision as to whose opinions he preferred. An inquisitorial medical tribunal approach encourages individual doctors to act genuinely as independent medical experts (removing any perceived taint as medical “guns for hire”, or, as it has been quaintly put, “rent-a-quacks”), and the final opinion is developed on a multidisciplinary collegiate basis. Opinions of the Victorian Medical Panels, the Western Australian Medical Assessment Panels and the Queensland Medical Assessment Tribunals are, by statute, final and binding. For example, section 68(4) of Victoria’s Accident Compensation Act 1985 states: The opinion of a Medical Panel on a medical question referred to the Medical Panel is to be adopted and applied by any court, body or person and must be accepted as final and conclusive by any court, body or person irrespective of who referred the medical question to the Medical Panel or when the medical question was referred. If South Australia had such a system, a panel of medical experts would have assessed Mr Simpson’s medical records and the expert evidence submitted both in support and rebuttal of the claim, made its own investigation of the literature, and come to an informed medical view. The panel would have had access to advice regarding the legal tests required by the appropriate statute. Whether the panel would have reached the same view as the judge cannot be said. But at least the medical basis for the claim would have been seen to have been thoroughly reviewed by truly independent medical experts — and a medical decision (subject to the law) made on a medical issue.

Paul Nisselle AM, MB BS, FRACGP

Kerry-Ann F O’Grady,* Terence M Nolan† * Senior Research Officer, Vaccine and Immunisation Research Group, Murdoch Children’s Research Institute, Flemington Road, Parkville, VIC 3052; † Head, School of Population Health, University of Melbourne, Melbourne, VIC. k.ogradyATunimelb.edu.au To the Editor: In Australia, personal and health information that identifies an individual cannot be used or disclosed for research without specific requirements being met.1 Even if these requirements are met, data custodians may still refuse access if their views are discordant with those of the relevant human research ethics committee (HREC). It is now evident that there are adverse consequences of this well-meaning legislation. Our research group conducts community-based vaccine trials. Recently, we attempted to use school enrolment lists to mail information to parents about a study. Despite approval from the Royal Children’s Hospital HREC, one major governing body of Victorian public schools rejected our proposal on privacy grounds, as did several independent schools. Only a small number of schools raised no privacy concerns at all. The main concern expressed was that the use of these registers for health research was not related to the primary purpose of collection, and families had not consented to this use. The net result was substantially reduced access to the population eligible for recruitment. We now have a situation in which the legislation may actually do more harm than good. This is an emerging issue here in Australia and overseas.2,3 Even more worrying are the findings of an Australian survey in which 61% of adults believed that even their de-identified health information should not be used for research purposes without their consent.4 Health research is dependent on access to population datasets to recruit participants, monitor health indicators, identify risk factors and inform interventions. Non-representative access threatens a study’s validity, resulting in poorly informed interventions, policy and funding decisions. The situation may now have progressed beyond reasonable trade-offs between the public good and individual privacy to the point where important research cannot be done at all, and the opportunity for advances in health are lost. Despite statutory guidelines,1,5 there are widespread differences in interpretation of the legislation, particularly regarding the terms “practicable” and “public good”. Amendment of the legislation in this respect is therefore urgently required, together with clauses which facilitate a researcher’s ability to inform the public of a particular project and enable individuals, not organisations, to decide whether they wish to participate. There needs to be greater effort in gaining public understanding of the legislation and its intent with respect to research. In addition, upfront declarations and “opt-out” clauses about the use of personal information for health research must also be included in the privacy statements that organisations are now legally required to provide to individuals at the point of data collection.

Kerry-Ann F O’Grady · Terence M Nolan

Paul Chadwick,* Beth Wilson† * Information Privacy Commissioner, † Health Services Commissioner, Office of the Victorian Privacy Commissioner, GPO Box 5057, Melbourne, VIC 3000. enquiriesATprivacy.vic.gov.au In reply: We are familiar with concerns such as those expressed by O’Grady and Nolan, and we are grateful for this opportunity to respond, so that readers can consider the views side by side. Privacy is not new. Ethical obligations of confidentiality in medical settings date back to Hipprocrates. New privacy legislation — Health Records Act 2001 (Vic); Information Privacy Act 2000 (Vic); Privacy Act 1988 (Cwlth) — clarifies these obligations and also sets a higher standard of accountability. (Other states and territories also have legislation or are contemplating it.) The new laws cover all sorts of personal information, but health information is especially delicate. Wrongly handled, it can lead to discrimination — not just embarrassment or loss of dignity. In Victoria, this was recognised by Parliament when it passed the Health Records Act as a separate piece of legislation to deal specifically with health information. The policy behind the privacy laws is aimed at promoting trust between health service providers and the public by reassuring them that their personal information will be respected, particularly in an electronic age in which information can be speedily transmitted far and wide. If surveys show the public to be wary about the use of their health information for research, it would seem to be in the best interests of the research community to embrace new standards rather than to seek to unravel or avoid them. Privacy legislation was drafted after extensive consultation, taking into account competing factors and the need to balance respect for privacy with other public interests, including research. Research is very important, and privacy is a cherished and longstanding value. Reputable research can coexist with the recent statutory expressions of privacy, just as reputable research has always coexisted with respect for privacy. Many data custodians perhaps do not yet realise that privacy laws rarely require an existing legitimate practice to cease completely, but rather may require the practice to be adapted to meet new standards. For example, for researchers seeking to recruit subjects for a study, the data custodian may disseminate the researchers’ initial letter rather than hand over lists of names and addresses to researchers. Once recipients opt in, direct consensual dealings with the researchers proceed as usual. Researchers can always use properly de-identified information, or they may use information with the consent of the subject. As with all new laws, the privacy laws will become better understood with time and experience. Some data custodians are understandably overcautious, while others have blamed privacy laws for preventing them from providing information in situations in which disclosure is permitted. Many adapt with ingenuity and effectiveness. Privacy Commissioners and the Health Services Commissioner are available to explain the laws. We, along with everyone with an interest in collecting and using the sensitive information of others, must recognise and consider the subtleties inherent in balanced privacy protection.

Paul Chadwick · Beth Wilson

The current practice of non-consensual medical treatment of hunger-striking asylum seekers in detention needs closer inquiry. An Australian Government regulation empowers the Department of Immigration and Multicultural and Indigenous Affairs (DIMIA) to authorise non-consensual medical treatment for a person in immigration detention if they are at risk of physical harm, but there are doubts about whether the regulation would withstand legal challenge. Authorisation by DIMIA does not compel medical practitioners to enforce treatment if such action is contrary to their “ethical, moral or religious convictions”. The World Medical Association has established guidelines for doctors involved in managing people on hunger strikes. The Declaration of Tokyo (1975) and the Declaration of Malta (1991) both prohibit the use of non-consensual force-feeding of hunger strikers who are mentally competent. If called upon to treat hunger strikers, medical practitioners should be aware of their ethical and legal responsibilities, and that they should act independently of government or institutional interests.

Mary A Kenny BJuris, LLB(Hons), LLM · Derrick M Silove FRANZCP, MD · Zachary Steel BA (Hons), MPsychol (Clinical)

If we can learn from this, it will have made a contribution to the pursuit of integrity in research On beginning his recent sabbatical at the Mayo Clinic, Professor Michael O’Rourke, a renowned academic from the University of New South Wales, was handed a slim volume entitled Honor in science. First published in 1984, it is recommended reading for research trainees as a guide to ethics and the values of research. Significantly, there are now more than 50 000 copies in circulation.1 Activities such as the dissemination of this booklet are central to ensuring society’s trust in the integrity of research. More than 20 years ago, Al Gore Jr (then a United States congressman, and later Vice President in the Clinton administration), as chairman of the first congressional hearing into scientific misconduct, noted: “At the base of our involvement in research lies the trust of American people and the integrity of the scientific exercise.”2 There is no reason to believe that this would be any different in Australia. Allegations of research impropriety affect the careers of both the accused and the accusers and . . . can divide an institution and damage its reputation. But trust in our research enterprise has recently been shaken by the “Hall affair” at the University of New South Wales (UNSW). At the end of 2001, complaints of research misconduct were levelled at Professor Bruce Hall, a Professor of Medicine at UNSW, and an internationally acclaimed scientist in immunology. The complainants were members of Hall’s research laboratory and it has taken more than 2 years to resolve their allegations. During this time, there were four different inquiries and reports, which reached different conclusions (see Box). From the beginning of the affair, all the allegations have been vigorously denied by Hall. Sadly, as it unfolded, the Hall affair illustrated the reality that allegations of research impropriety affect the careers of both the accused and the accusers and, in the process, can divide an institution and damage its reputation.11 Most importantly, such allegations jeopardise public trust in the integrity of research. Further, they provide fuel for a media that feeds on human discord, and, dealing in perceptions and innuendo, accelerate this corrosion. The Hall affair was first publicly dramatically exposed on the Australian Broadcasting Corporation (ABC) Radio National’s Science Show,4 and then clinically dissected by ABC television’s Four Corners9 (see Box). The media also covered the investigation as it progressed and, on the release of the UNSW Vice-Chancellor’s Report on the affair,8 one journalist commented, “Let me get this straight. Plucking data from thin air, recycling old research in new papers and telling porkies in a grant application is OK. Funny, I thought such doings were serious no-nos, construed at best as scientific misconduct, or at worst scientific fraud. Apparently not . . .”12 Looking back over the Hall affair, we are forced to ask ourselves how we can move forward. Are there any lessons to be learned? Scientific misconduct and fraud may well be seen as an illness, requiring not only diagnosis but also treatment. The diagnosis involves a fast and fair inquiry which, at the same time, must assure the public of its propriety. Unhappily, the Hall affair dragged on for more than 2 years and involved at least four inquiries (see Box). The initial inquiry by the UNSW’s Dean of Medicine should not have moved beyond a prompt and preliminary process to establish whether there was a case to be answered. In any event, it went on, patently crippled by perceptions of conflicts of interest — including an institution investigating allegations of improprieties carried out in its own backyard! Herein lies lesson number one — once allegations of scientific misconduct and fraud have been made, these should be addressed from the beginning by an external and independent inquiry. The external inquiry must establish the evidence for misconduct. From the publicly available details of the Brennan Inquiry,7 it appears the inquiry had its hands tied in testing the evidence. Herein lies lesson number two — the external inquiry should have statutory power to investigate and inquire. Defining this power will not be straightforward, as the inquiry should not be hijacked by obfuscating and delaying legal tactics. The Brennan Inquiry was made up of legal and scientific experts, with the latter in the majority. Despite the fact that the framework of research conduct is generic, professional criticisms surfaced in the Four Corners program9 and elsewhere about the inquiry panel’s lack of expertise in immunology.10,13 To allay public concerns about the lack of relevant “expertness” — inquiries into allegations of scientific misconduct and fraud should consider having on the panel of inquiry at least one expert from the same scientific discipline as the scientists under investigation — lesson number three! In the 2002 Reith Lectures for the British Broadcasting Corporation, Onora O’Neill stated that “. . . ‘Loss of trust’ is, in short, a cliché of our times.”14 Mistrust of professionals, politicians and public servants and their institutions permeates our society. The antidotes to this “culture of suspicion” are supposedly higher standards of accountability and greater transparency.14 As it progressed, the Hall affair was not the epitome of transparency and, to date, the details of its four inquiries remain cloistered within academia. Herein lies lesson number four — to preserve public confidence, inquiries into scientific misconduct should aim for the highest degree of transparency and accessibility of final reports. Finally the Vice-Chancellor’s Report (see Box) makes judgements on the outcomes of the Brennan Inquiry, and also conveys opinions on the relative value of scientific abstracts and the nature of data in research-funding applications that are at odds with conventional scientific wisdom. Even more intriguing is the rationale behind the action of the Vice-Chancellor in judging the findings of the Brennan Inquiry, yet not consulting its panel. Why bother with an external inquiry if its outcomes are to be subsequently interpreted and judged by an individual calling on his own wisdom along with the views of another battery of experts? Such action may be in accordance with and required by the UNSW enterprise agreement, but surely the integrity of research transcends any industrial agreement! Herein lies lesson number five — universities, research institutions, research societies, societies and funding bodies need to collectively define uniform processes and procedures for addressing and adjudicating on scientific research and fraud.15 But what about treatment? The emphasis in healthcare today has shifted from the management of diseases to their prevention, and herein lies lesson number six — there is a need to shift the emphasis from managing scientific misconduct and fraud to preventing them. This shift is thoroughly summarised in the recent report of the United States Institute of Medicine (IOM), Integrity in scientific research: creating an environment that promotes responsible conduct.16 Its central theme is the need to foster responsible research conduct, and it identifies the individual scientist as the most unpredictable variable in the equation. But it also throws back to institutions the responsibility of creating a culture that values research integrity through comprehensive and effective education, self-assessment and self-improvement, aimed at both the individual and the institutional level. In short, the IOM report moves the prevention of research misconduct from focusing on what we should do in the conduct of research, as prescribed in guidelines, codes of conduct and other affirmations or declarations, to determining what we actually do through individual and institutional self-assessment, and moving to best practice through education and continuous improvement underpinned by a reward system. The IOM report lists desirable goals for both individuals and institutions in maintaining scientific integrity, but, ultimately, research is an intense and complex human exercise — one which sees young investigators and their mentors working in a “pressure-cooker” environment, where the only safety valves are open communication, mutual respect and mentors prepared to be actively involved. In his 1982 Presidential Address to the American Society for Clinical Investigation, Phillip Majerus (Professor of Medicine, Biochemistry, and Molecular Biophysics at Washington University, and past editor of the Journal of Clinical Investigation) describes this ideal environment: “Students, postdoctoral fellows and junior colleagues are the future of medical research. They are our most valuable resource and should be treated as such. Senior investigators have a solemn responsibility to guide trainees to allow them to express their full potential. If because of clinical, administrative or other constraints, an investigator does not have time to participate in the ongoing progress of an investigation on a day-to-day basis, then he should dissociate himself from it . . . Work in progress should be discussed openly and the data should be reviewed, frequently, not just by the laboratory chief but also by disinterested parties. Group meetings of large laboratories where there is evaluation of data of individuals are important. Even better are presentations to departmental or other groups, where investigators not directly connected with the work, evaluate the data. These exercises require heavy applications of skepticism, the most important ingredient in scientific creativity.”17 Good advice then and good advice now. The Hall affair has wreaked untold havoc, but, despite this, can be viewed in a detached, scientific sense as experiments in processes and procedures. The results of experiments need to be mulled over and interpreted to determine future directions. In this vein, the Hall affair should make a contribution to the pursuit of research integrity. Ultimately, integrity in research requires leadership. If, in the wake of the Hall affair, our universities cannot ensure an enlightened and responsible ethos in their research enterprises they risk a loss of public confidence. The ball is in their court. The “Hall affair” — investigations of complaints against Bruce Hall, Professor of Medicine at the University of New South Wales September 2001 – January 2002 Complaints received by the University of New South Wales (UNSW) from three members of Professor Hall’s laboratory, which, among other things, raised allegations of scientific misconduct and fraud, as well as deficiencies in workplace relationships and procedures.3 13 April 2002 Dr Norman Swan revealed details of the complaints against Professor Hall, and discussed these with the complainants on the Australian Broadcasting Commission Radio National’s Science Show.4 Hall, at all times, fiercely denied these allegations. 17 April 2003 The UNSW released the outcomes of two parallel internal inquiries by Professor Bruce Dowton, Dean of the Faculty of Medicine, who carried out the initial investigation of the complaints, and Professor Elspeth McLachlan, Pro-Vice-Chancellor (Research), who focused on complaints that had been raised with the National Health and Medical Research Council. Both inquiries found no overwhelming evidence to sustain the complaints. Both were unable to report conclusively on some matter of alleged scientific misconduct and fraud.3 As to the workplace complaints, the inquiries found there were unsatisfactory working relationships and an unsatisfactory working environment in Hall’s laboratory.3 UNSW Vice-Chancellor John Niland announced the setting up of an external inquiry to address the allegations of scientific misconduct and fraud as defined by the National Health and Medical Research Council and the Australian Vice-Chancellors Committee (NHMRC/AVCC) Joint Statement and Guidelines on Research Practice.5 June 2002 The UNSW announced the members of the external independent inquiry, who were: Sir Gerard Brennan, previous Chief Justice of the High Court (chair); Professor John Chalmers of the University of Sydney; Sir David Weatherall of Oxford University; and Professor Judith Whitworth of the Australian National University.6 Subsequently, it become known as the Brennan Inquiry. January 2003 The UNSW received the final report of the Brennan Inquiry, after which the Hall Affair proceeded along two pathways: (a) matters related to the release of the Brennan Inquiry report; and (b) processes required to comply with the University Enterprise Agreement in dealing with allegations of research misconduct. Events were as follows: (a) On 14 February 2003, the UNSW Council resolved not to release the Brennan Inquiry report, and also considered a submission by Professor Hall as to why its release should not occur. Ten days later, the Council reversed its position and sanctioned limited release. The following day (24 February), lawyers for Hall obtained a temporary injunction against its release. In August 2003, Justice McLennan lifted the injunction.7 (b) To satisfy the provisions of the UNSW Enterprise Agreement for pursuing alleged research misconduct, the Brennan Report was referred to Professor Stephen Deane, Professor of Surgery at Liverpool Hospital, acting as Hall’s academic supervisor at Liverpool Hospital. The UNSW Enterprise Agreement sets out a detailed process to be followed in cases of alleged research misconduct, so that the UNSW may only discipline an academic if the Enterprise Agreement process has been complied with. Professor Deane’s remit was to determine whether the Brennan Inquiry report gave rise to any allegations of misconduct or serious misconduct as defined by the Enterprise Agreement and, if so, whether such allegations could be “resolved through guidance, counselling, conciliation or other appropriate action.”8 Professor Deane provided a report (the Deane Report) on 17 March to UNSW Deputy Vice-Chancellor, Professor Mark Wainwright. Based on the Deane and the Brennan Inquiry reports, Professor Wainwright identified 12 outstanding allegations against Hall which warranted further investigation. Professor Hall was given the opportunity to respond to these allegations. Ultimately, Professor Wainwright determined that, in relation to six allegations, there was no misconduct or serious misconduct. However, for the remaining six he was unable to determine whether or not serious misconduct had occurred. Hall was notified of these allegations, which he denied, but he elected to have the matter referred directly to the Vice-Chancellor. 6 October 2003 An ABC Four Corners program presents the central concerns and provides real-life insights into the key players in the Hall Affair.9 23 December 2003 UNSW releases the report by the Vice Chancellor, Rory Hume, on findings of allegations of misconduct.8 In reaching his decision, Hume considered the Brennan Inquiry report and the views of two experts, along with a written response from Hall, which included reports by six experts in immunology. Professor Hume considered the allegations only in the terms of the Enterprise Agreement and, where indicated, the NHMRC/ACVV statement and guidelines.5 His findings are shown below. Allegation 1: A paper that was submitted or authorised to be submitted contained data and statements for which there were no supporting experiments. Finding: Professor Hall was not guilty under the Enterprise Agreement. Rather he had committed an error of omission reflecting the pressure of mitigating circumstances.* Allegation 2: A grant application by Professor Hall contained a figure with a conclusion “all differences are significant at P < 0.05”, but omitted relevant facts. Finding: Guilty of misconduct, but, given the mitigating circumstances* and the Vice-Chancellor’s belief that grant proposals are preliminary data yet to be validated and that there was no intention to deliberately deceive, he deemed the transgression to be minor and warranting no further action. Allegation 3: A grant application by Professor Hall contained a statement when no experiments to support the statement were ever done in Hall’s laboratory or in the laboratory of any other author of the grant application. Finding: Guilty of misconduct despite the mitigating circumstances.* Hall was censured. Allegation 4: Failure to notify the granting body of the details once the absence of the experiments outlined in Allegation 3 became apparent. Finding: Guilty of misconduct warranting censure. However, Professor Hall’s lack of action did not demonstrate an intention to deceive. Allegation 5: The publication of an abstract which contained a statement for which no experiments were performed in Hall’s laboratory. Finding: Guilty of misconduct in failing to take reasonable steps to ensure that the abstract was accurate, but, in view of mitigating circumstances,* including the Vice-Chancellor’s view that “abstracts have very little potential to damage the fabric of science,” along with the premise that individuals’ interpretations of the abstracts differ, no further action was taken. Allegation 6: That Professor Hall must accept the main responsibility for allowing a substantial degree of procedural laxity in his laboratory at Liverpool Hospital. Here, there were mitigating circumstances* against a background of a complex research laboratory and Hall’s need to supervise a busy clinical service and a teaching program. Finding: Guilty of misconduct. Hall was advised of his error of judgement, but, given the circumstances, no further action was taken. In summary, the Vice-Chancellor did not believe that Professor Hall was guilty of scientific misconduct. Rather, he committed errors of judgement sufficiently serious in two instances to warrant censure. None of the Vice-Chancellor’s findings warranted Hall’s dismissal. With the release of the Vice-Chancellor’s findings, one prominent immunologist was quoted as saying that the allegations against Hall were “much ado about nothing”.10 * During the period when some of the alleged misconduct occurred, Hall was afflicted by a debilitating illness, his laptop and disks containing grant proposals were stolen, and he was subject to the pressure of tight deadlines.

Martin B Van Der Weyden MD, FRACP, FRCPA

Recruitment by wealthy countries of health personnel from developing countries is threatening the viability of crucial health programs in poor countries, especially in sub-Saharan Africa. Australia has participated in this “brain drain”, although the extent and impact of this on different countries has not been adequately assessed. Australia depends on overseas-trained doctors to fill vacancies in public hospitals and private practice, particularly in rural and outer suburban areas where locally trained professionals are reluctant to work. Australia should adopt national strategies to minimise harm and maximise benefits of skills migration; concerted international action will also be required.

Mark L Scott BA · Anna Whelan PhD, AFCHSE · John Dewdney MD, SM, DPH · Anthony B Zwi MB ChB, PhD, AFPHM

Communicating with vulnerable children: A guide for practitioners. David P H Jones. London: Gaskell, 2003 ($72.00, xvi + 188 pp). ISBN 1 901242 91 9. David Jones is well recognised for his research into the reliability of child testimony. This text provides a primer on good professional practice for interviewing children, based on current scientific evidence. This is an essential area of competence for the ever-increasing range of professionals working with children who have experienced adversity or abuse. This book provides a comprehensive and well-organised summary of the area, and is relevant to all those who may communicate with vulnerable children, including professionals from health, education, welfare and the law. It describes the process of enabling children to communicate freely and honestly, and to impart reliable and accurate information. The book is based on relevant research and clinical experience. As well, it has been carefully edited by an advisory board from the Department of Health and the Family Division of the High Court of Justice in the United Kingdom, with the aim of improving practice and reducing the amount of malpractice in communication with children. The first section covers the knowledge base of influences on childhood communication and interviewing style. It includes developmental limitations and considerations, especially regarding memory and language, and the influence of social context, including disability and culture. Childhood reliability in providing information is a small, though important, part of the problem of “erroneous concerns” in the system of child protection and notification, and the chapter about these issues helps refocus on the practitioner’s responsibility for unreliability. The second section guides practice at the different stages of communication, including response to first concerns, initial assessment and in-depth interviews. It also contains helpful chapters on the problems of using communication aids such as anatomically correct dolls, and advice on coping for parents. Medicolegal sensitivity means that this book is not always light reading and more case examples and diagrams would help improve accessibility. While full of useful details for even the most experienced clinicians, problems of development and mental health require more knowledge and expertise than is provided here. On the whole, a wide range of detailed information and practical advice is clearly presented, and we would recommend this as a comprehensive and common sense introductory text for all those who understand children, and essential reading for those who don’t. Emma HartwellPsychologist David R DossetorDirector of Mental Health Children’s Hospital at Westmead, Sydney, NSW

Emma Hartwell

A recent High Court decision has held that parents are entitled, in addition to the usual costs arising from a failed sterilisation, to the reasonable costs of raising a healthy child. In the recent case of Melchior v Cattanach and State of Queensland, a majority in the Queensland Court of Appeal1 and in the High Court2 upheld the finding by the trial judge (Holmes J) that a doctor must pay for all the reasonable costs of raising Jordan Melchior, a healthy boy born as a result of a failed sterilisation. The defendant doctor’s negligence was said to consist of an unreasonable reliance on the history he was given by the plaintiff that her right fallopian tube had been removed, together with her right ovary, during an appendicectomy some 15 years earlier. In fact, the right tube was present and patent. (The doctor’s postoperative notes, after performing a left tubal ligation, stated “Good view small bowel associated with right adnexal area — extensive adhesions. No right tube or ovary visible. Consistent with patient’s history of right salpingo-oophorectomy.” We now know that the right fallopian tube was obscured from view by the bowel adhesions.) Holmes J doubted “that the history [the doctor] obtained could be described in any more than a superficial sense, although he clearly perceived it as so. A little more probing may well have revealed its dubious quality.” Her Honour concluded that, in the circumstances, it was incumbent on the doctor to advise the patient that a procedure (namely, a hysterosalpingogram) was available for detecting whether a functioning fallopian tube was present. I believe that the finding of negligence was highly dubious. It was certainly received less than enthusiastically by the Court of Appeal. In the judgment handed down by the Court of Appeal,1 the sole reference to the issue of negligence was by Thomas J, who stated, “With some hesitation I have taken the view that the view taken by the learned trial judge was open, although it is not a view that her Honour was bound to take or that I think I would have taken.” The significance of the case therefore turns on the controversial award of damages for the cost of raising Jordan up to the age of 18 years. Throughout the case presented at the trial and on appeal (and, indeed, in similar cases in the United Kingdom and the United States) the damages (ie, the cost of raising a child conceived as a result of a failed sterilisation) were labelled as flowing from a “wrongful birth” (ie, a birth that would not have happened except for the defendant’s alleged negligence). That description obscures the reality, namely that Jordan is, in the eyes of the law, an unwanted child whose parents chose to keep him — and sue — rather than mitigate their “loss” by placing the unwanted child for adoption. Has the law any place in the area of human reproduction? In posing that question in the High Court appeal,2 Chief Justice Gleeson, albeit in the minority, answered this question as follows: In deciding whether, in contemplation of the law, the creation of [the parent–child relationship] is actionable damage, it is material to note that it is unlikely that the parties to the relationship, or the community, would regard it as being primarily financial in nature. It is a human relationship, regarded by domestic law and by international standards as fundamental to society. To seek to assign an economic value to the relationship, either positive or negative, in the ordinary case, is neither reasonable nor possible. Without going into the extensive and complex reasoning of each of the judges involved in the case, I will attempt to summarise the views of the majority in the High Court (McHugh, Gummow, Kirby and Callinan JJ), and will briefly discuss the decisions of the dissenting judges (Gleeson CJ, Hayne and Heydon JJ).2 Of the majority, Kirby J (whose views were largely shared by the other judges of the majority) reviewed the relevant law in depth, both in Australia and in the United States, the United Kingdom, Canada, New Zealand and South Africa, as well as the approaches of the civil law in some European countries. His Honour noted that in the United States only a small number of states allow full recovery for the ordinary costs of raising a healthy child born after a failed sterilisation or a failure to adequately warn of potential failure. He further noted that in the United Kingdom the law on the subject had recently veered sharply against awarding damages of the kind at issue in Melchior v Cattanach. In a House of Lords decision, McFarlane v Tayside Health Board,3 their Lordships were unanimous in concluding that the parents of a healthy child, born in consequence of alleged medical malpractice, were not entitled to recover from the doctor the cost of reasonable maintenance of the child during his or her minority. (The word healthy is highlighted here, for reasons that will be discussed below.) Kirby J observed that the common law does not exist in a vacuum and that it had to respond to the ever-increasing claims by disappointed parents who had undergone sterilisation operations — in preference to using contraceptive devices — only to discover that the operations had failed and that they were burdened by an unwanted child and by short-term and long-term losses: What commenced as a relatively small number of cases is now a substantial and growing body of decisional law, not only in common law countries but also in countries with a civil law system.2 In what Kirby J described as an attempt to “stem the tide of such claims”, Jupp J, in the UK case Udale v Bloomsbury Area Health Authority,4 awarded the mother, over and above an amount for pain and suffering and loss of earnings during pregnancy, a small amount for the disturbance of family finances caused by the unexpected conception. However, Jupp J firmly rejected the mother’s claim for the cost of raising the child up to the age of 16, such a claim being regarded as “contrary to public policy, being disruptive of family life and inconsistent with the sanctity of human life”.2 Kirby J continued: As more such cases came before the courts differing views soon emerged. The approach of Jupp J was not followed in a number of the English cases that ensued, including Emeh v Kensington and Chelsea and Westminster Area Health Authority,5 Thake v Maurice6 and Benarr v Kettering Health Authority.7 In those cases, the judges rejected the argument that public policy prevented recovery of damages for the cost of child-rearing [and asserted that] the normal legal principles of recovery of damages would apply. A person injured through the negligence of another could recover damages on the compensatory principle for all losses that were reasonably foreseeable to the tortfeasor [(wrongdoer)] at the time of the wrong. Such losses included . . . the basic costs of child-rearing.”2 It is important to note here that the three cases cited by Kirby J were all first-instance cases whose arguments were soundly rejected by a unanimous House of Lords in McFarlane v Tayside Health Board,3 the first occasion the issue was taken on appeal to the House of Lords. The majority in the High Court having firmly rejected the “English” view (ie, that damages for the cost of child-rearing should not be claimable), their Honours thus gave their imprimatur to earlier Australian cases dealing with an unwanted child, the most significant decision being CES v Superclinics (Australia) Pty Ltd.8 That case was an instance of repeated negligent misdiagnosis of the plaintiff’s pregnancy, thus depriving the mother of the chance to procure a lawful abortion which, she claimed, she would have undergone. On appeal to the New South Wales Court of Appeal (of which Kirby J was then President), the three judges were divided in their opinion. Although Kirby P and Priestley JA both upheld the appeal, they did not agree on the extent of damages the unmarried parents of the unplanned child could recover. Kirby P would have allowed full recovery for the upbringing of the unwanted child. Priestley JA believed that the parents should be entitled to damages relating to the pregnancy and the period shortly afterwards, but not to damages that were too remote or unforeseeable. He argued that . . . after a very short interval, the parents could have surrendered the child for adoption. The mother’s decision to keep the child was her own choice. After that decision was made, the defendant was not legally responsible for the parents’ financial costs of rearing the child. (Restated by Kirby J in the High Court case.2) In his dissenting view in the CES appeal case,8 Meagher JA stated that the parents’ claim was “utterly offensive” and that “there should be rejoicing that the hospital’s mistake bestowed the gift of life upon the child”. He concluded that no damages for rearing the child could be recovered. In Cattanach v Melchior, Kirby J (now a member of the High Court) noted somewhat dismissively, in relation to Meagher JA’s decision in the CES appeal, that “lying deep in many of the judicial opinions are perceptions of moral or ethical factors, illustrated by recourse to Biblical citations.”2 Given such divergent views, Kirby J stated in the High Court that, when sitting in the Court of Appeal, he had reluctantly agreed with Priestley JA, whose views expressed “the highest denominator of the majority”, in order to “provide guidance . . . to trial courts generally”.2 He restated his own view in the High Court: The application of the general rule, requiring the tortfeasor to pay the victims of the wrong for the reasonably foreseeable consequences of any proved negligence, obliges the inclusion in the recoverable damages of a sum for the costs of child-rearing. Clearly such costs are within the ambit of the compensable principle required by “corrective justice”.2 I suggest that the major difference between the majority and minority views in Cattanach v Melchior2 turns, in the main, on whether the law should distinguish between claims of negligence brought by parents who bear a child with a disability and parents who bear a healthy child after a failed sterilisation. Kirby J adopted the view that this differentiation . . . is arbitrary, and therefore unacceptable as a statement of the common law. In Australia, even the description of such parents as “afflicted with a handicapped child” would be offensive to most such parents and contrary to their attitudes about themselves, their child and others.2 The three minority High Court judges, on the other hand, upheld the defendants’ argument that the birth of a normal, healthy child should not be regarded as a legal harm or wrong for which damages may be awarded: [The contrary arguments] are unsound because they take insufficient account of the law’s assumptions about some key values in family life as reflected in the unenacted and enacted law. They also take insufficient account of the type of litigation that is likely to take place if recovery of rearing costs is permitted.2 Against that background, it is interesting to briefly review the speeches of the House of Lords in McFarlane v Tayside Health Board.3 Three of their Lordships (Lords Slynn, Steyn and Hope) characterised the costs of bringing up the child as “pure economic loss”. In denying the claim, these Law Lords identified the relevant question as being “whether the doctor had owed the patient a duty to take reasonable care in giving advice which was a duty that protected the patient’s economic interest”. Lord Slynn concluded that there was no duty of any kind, because the doctor had not assumed a responsibility for the expense of rearing the child. Lord Steyn invoked notions of “corrective” and “distributive” justice, concluding that “commuters on the Underground” would not accept that to impose such a liability would be a “just distribution of the burden and losses among members of the society”. Lord Hope expressly invoked the tripartite test of what is “fair, just and reasonable” — commonly used in the United Kingdom to ascertain the existence of a duty of care — to conclude that “the cost of bringing up the child should not be recoverable while, at the same time, denying that the cost of maintenance had been shown to exceed the value of parenthood”. (Quoted from Hayne J in the High Court case.2) Lord Millett adopted the same view voiced by Meagher JA in the CES case,8 namely that “the law must take the birth of a normal, healthy baby to be a blessing, not a detriment”, adding that, although a mixed blessing, “society must regard the balance as beneficial” and that it would be “subversive of the mores of society for parents to enjoy the advantages of parenthood while transferring to others the responsibility which it entails”.3 It is beyond the scope of this article to examine in detail the views of the High Court judges on the role of “choice” — ie, the exercise of the parents’ choice whether to keep Jordan or place him for adoption, thus exploring the “mitigation” principle enshrined in the law of torts. Neither is it appropriate to discuss at length the role public policy plays in the development of the common law, or, indeed, whether human life can be assigned a monetary value. Suffice it to say that a bare majority agreed that the primary judge was correct in concluding that Dr Cattanach’s “negligence” was the causative — and reasonably foreseeable — factor in the parents incurring the cost of raising Jordan up to the age of 18 years, being an economic loss of a kind for which the defendants were liable. The possibility that Jordan may eventually discover that he was born unwanted produced some caustic observations from some members of the minority. Heydon J noted: Since there is a question whether a rule of law exists which permits parents to recover from negligent defendants the cost of rearing children, it is relevant to consider the consequences of the rule. The rule under consideration would encourage parents both to exaggerate and to denigrate their children’s aptitudes. The rule would encourage parents to search for characteristics of the children which might call for future expenditures with a view to recover monetary compensation to meet those possible expenditures.2 In perhaps the most biting indictment of this “rule”, Heydon J quoted Meagher JA’s warning in the CES case:8 Having given birth to a healthy child in August 1987, the parents claimed at a court hearing in December 1993 that the child, then over six years old, was unwelcome, a misfortune, perhaps a disaster, certainly a head of damages. For all I know the child was in court to witness her mother’s rejection of her. Perhaps, on the other hand, the plaintiff had the taste to keep her child out of court. Even if that be so, it does not mean that the unfortunate infant will never know that her mother has publicly declared her to be unwanted. When she is at school some âme charitable — perhaps the mother of one of her “friends” — can be trusted to direct her attention to the point. That a court of law should sanction such an action seems to me improper to the point of obscenity. In contrast, none of the majority in the High Court dealt with the issue of the potential effect on the child of discovering that he was unwanted and the subject of legal proceedings. I believe the case of Cattanach v Melchior was one in which an unfortunate factual finding, at first instance, gathered its own momentum, allowing judicial adventurism to triumph, the majority accepting a result that other judges regarded as an “obscenity”. The civil law has always shown more caution in imposing tortious liability for negligent acts affecting purely financial interests than it applied to negligent acts causing damage to person or property. At common law, the death of a human being is still a damnum sine injuria (ie, a loss for which the law provides no remedy).9 It required Acts of Parliament in all common law countries to allow specified dependants to sue for damages if death was the result of a negligent act. Why should “legal remedies consequent upon the birth of a healthy child, which all of us regard as a good thing”3 be left to the personal views of common law judges? In the words of Gleeson CJ, quoting from Brennan J in another Australian case,10 “The accepted approach in this country is that the law should develop novel categories incrementally and by analogy with established categories.”2 The majority in the High Court case clearly did not heed that “accepted approach”.

Paul Gerber LLB DJur

Lynne M Roberts,* Lucy Bowyer,† Caroline S Homer,‡ Mark A Brown§ * Research Midwife [corresponding author], † Senior Lecturer in Obstetrics (University of New South Wales), ‡ Midwifery Consultant, Department of Women’s and Children’s Health, St George Hospital, Research Building, St George Hospital, Kensington Street, Kogarah, Sydney, NSW 2217; § Professor of Medicine (University of New South Wales), Department of Renal Medicine, St George Hospital. RobertslyATsesahs.nsw.gov.au To the Editor: The obstacles presented by Human Research Ethics Committees (HRECs) have caused a significant delay in commencing a valuable research project. We are currently conducting a multicentre study investigating the outcomes of hypertensive pregnancies in a cohort of 1620 women. It is a retrospective review of medical records and does not entail any participation of the women. Ethics approval was sought and gained from the New South Wales Health Department and one other NSW area health service (AHS) involved in the study. The bulk of the medical records (85%) are held by this AHS and a smaller proportion by eight other AHSs in NSW. Despite these prior approvals, the process of gaining ethics approval from the eight AHSs was fraught with obstacles at every stage. After 8 months’ work, we have received approval from the HREC of each of the AHSs. Our experience has revealed many inconsistencies in the requirements of the HRECs in the different AHSs, as summarised in the Box 1. These inconsistencies highlight discordances with the guidelines to support researchers and HRECs drawn up by the National Health and Medical Research Council (NHMRC). The NHMRC’s National Statement on Ethical Conduct in Research Involving Humans1 clearly outlines that, once approval has been gained from one HREC, other sites should accept that approval. Unfortunately, it seems that the HRECs involved in giving approval for our study did not follow the guidelines relating to multicentre projects. Other researchers have reported similar problems. 2-4 Breen and Hacker2 suggest that HRECs are slow to adopt a simplified review process because this interferes with traditional practices of each committee making its own assessment. It is indisputable that ethics considerations are a vital component when undertaking human research. It is also crucial to have a reliable and trustworthy process that evaluates research proposals in order to protect participants from physical and psychological harm. However, it has taken the research midwife (who is on a 1-year non-renewable grant) 8 months to secure ethical approval at all sites. This process is cumbersome and counterintuitive to the principles and guidelines for multicentre research in this country. 1: Summary, by area health service (AHS, coded S to Z), of different requirements for gaining ethics approval for a multicentre study Area health service S T U V W X Y Z No. of pages of application form 19 20 19 20 12 23 2 11 No. of copies of form required 1 1 17 15 20 16 1 14 No. of hospitals in AHS covered by approval 2 2 4 1 3 5 3 5 Approval covered private hospitals in AHS also na na Yes No No na No na No. of contacts made (phone/letter/email) to gain approval 20 15 20 15 20 30 10 20 Time taken to gain approval 3 months 5 months 4.5 months 8 weeks 6 weeks 6 weeks 1 week 3 weeks Special requests during approval process A F A, B, C, E A A, D A G, H Approved after first submission Yes No No Yes Yes Yes Yes Yes na = not applicable. A = Asked for local researcher to be a contact person for the study. B = Charged a $33 fee to submit application. C = Requested scientific protocol with references. D = Requested budget form. E = Reviewed by scientific advisory committee before human research ethics committee (HREC). F = Requested consent and subject information forms. G = University HREC’s approval as well as approval of area health service HREC required. H = Final approval required from chief executive officer of major hospital in that AHS.

Lynne M Roberts · Lucy Bowyer · Caroline S Homer · Mark A Brown

Objective: To determine how familiar human research ethics committees (HRECs) are with the principles of natural justice and whether they apply these principles.Design and setting: A postal survey conducted between April and September 2002 of the Chairs of all HRECs registered with the Australian Health Ethics Committee of the National Health and Medical Research Council (NHMRC) in 2001.Main outcome measures: HRECs’ reported familiarity with, and application of, three principles of natural justice: (1) the hearing rule, requiring a decision maker to allow a person affected by a decision to present his or her case; (2) the rule against bias, requiring a decision maker to be unbiased in the matter to be decided; and (3) the evidence rule, requiring that a decision be based on the evidence provided, and not irrelevant issues.Results: From 201 Chairs of HRECs Australia-wide, we received 110 completed questionnaires (55% response rate). About 33% of respondents were very familiar with the principles of natural justice, and 25% completely unfamiliar. Most respondents felt that natural justice should be, and usually is, applied by HRECs. In cases of possible positive bias of an HREC member towards a research proposal, 70% of respondents said they would exclude the member from decision making. In cases of possible negative bias, 43% said they would exclude the HREC member.Conclusion: The degree of familiarity with principles of natural justice varies widely among Chairs of HRECs. While many respondents felt that HRECs usually apply natural justice, responses to questions about bias suggest that HRECs do not always exclude members with possible bias, contrary to NHMRC guidelines.

Gabrielle L Van Essen CertNurs, MB BS, FANZCA · David A Story BMedSci(Hons), MB BS(Hons), FANZCA · Stephanie J Poustie BN, CritCareCert, MPH · Max M J Griffiths MBE, BA, BD · Cynthia L Marwood LLB, LLM